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Effect of S-Ketamine on Body Perception in Healthy Adults

Effect of S-Ketamine on Body Perception in Healthy Adults - S-Ketamine on body perception - the ESKOP study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON53181
Enrollment
24
Registered
2023-03-27
Start date
2024-10-14
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The research will be conducted with healthy volunteers and no patients are involved.

Interventions

In the S(+)-ketamine session, subjects will receive an intravenous (IV) administration of a continuous infusion of 20 mg /h (per 70 kg) for 1 hour, followed by an infusion of 30 mg /h (per 70 kg) for
session, participants will receive an IV administration of 50ml of saline solution.

Sponsors

Universiteit Leiden
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. Healthy male or female volunteers; 2. Age: 18 - 40 years; 3. Body mass index < 30 kg/m2; 4. Able to give informed consent; 5. Be able to speak and understand English.

Exclusion criteria

Exclusion criteria: 1. Known or suspected neuromuscular or a (family) history of any neuromuscular disease; 2. A history of allergic reaction to food or medication including study  medication;3. Any current or previous medical (including high blood pressure),  neurological or psychiatric illness (including a history of anxiety);4. Alcohol abuse (> 21 units/week);5. Illicit drug use in the past 30 days before inclusion;6. Pregnancy or lactation;7. Participation in any medical or drug trial in the month prior to the current study

Design outcomes

Primary

MeasureTime frame
The primary outcome measures are the neural and behavioral effects of S-ketamine relative to placebo. Specifically, we examine the neural effects of S-ketamine on event-related potentials (ERPS) in a sensory suppression task and in a sustained attention task. Additionally, we examine the effects of S-ketamine on perception of body perception and agency, feelings of feelings of embodiment and perception of heart rate, through behavioral-experimental tasks and measurements.

Secondary

MeasureTime frame
The secondary outcome measures of this study are the effects of S-ketamine on subjective perception, measured by questionnaires and an interview; the relationship between the subjective measures and neural and behavioral effects; and the relationship between personality factors and subjective effects.

Countries

Netherlands

Contacts

Public ContactMvE Michiel van Elk

Universiteit Leiden

m.van.elk@fsw.leidenuniv.nl0031614258152

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)